Trial Title:
the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening
NCT ID:
NCT05870696
Condition:
Colorectal Adenoma
Conditions: Official terms:
Adenoma
Conditions: Keywords:
colorectal adenomas; colorectal cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PrecogColo Dx test
Description:
the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia
Screening, including advanced adenoma and colorectal cancer
Arm group label:
Positive
Arm group label:
negative
Summary:
This study is to Evaluate the diagnostic sensitivity of the serum metabolite based
PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced
adenoma and colorectal cancer. There are two steps in this study. Firstly, the diagnostic
model is established based on tumor-specific and gut-microbiome related serum
metabolites. Secondly, the sensitivity, specificity and accuracy of the diagnostic model
is evaluated in detecting advanced adenoma and colorectal cancer stages in an independent
multi-centered cohort.
Detailed description:
Subjects aged >45 at average risk for development of CRC will be enrolled. Subjects will
complete the PrecogColo Dx test, followed by completion of a screening colonoscopy. .
Results from PrecogColo Dx test were compared to the results of an optical colonoscopic
examination, and histopathological diagnosis of all significant lesions discovered during
the colonoscopy, in order to determine the sensitivity for CRC and advanced adenoma,
respectively, as well as determining specificity of non-advanced neoplasia individuals.
Histopathological results from biopsied tissue or excised lesions were categorized based
on the most clinically significant lesion present by a central pathologist.
Criteria for eligibility:
Study pop:
Subjects 45 years of age and older who are eligible for colorectal cancer screening and
scheduled for a screening colonoscopy. Approximately 2,000 subjects will be targeted for
enrollment.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Subject is ≥ 45 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy.
3. Subject has no symptoms or signs that require immediate, or near term, referral for
diagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent.
Exclusion Criteria:
1. Patients received tumor treatment prior to the drawn of blood sample, including
surgical resection, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and
targeted therapy.
2. Patients received antibiotics within 2 weeks.
3. Patients with indications of emergency surgery, including bleeding, obstruction and
perforation.
4. Patients who are positive for Human Immunodeficiency Virus (HIV).
5. Patients with abnormal liver and kidney function.
6. Patients with the history of inflammatory bowel disease.
7. Patients who had history of other malignancies.
8. Subject has a diagnosis or medical history of any of the following conditions:
1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated
FAP and Gardner's syndrome)
2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch
Syndrome")
Gender:
All
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Huaxin Hospital
Address:
City:
Beijing
Zip:
100016
Country:
China
Status:
Recruiting
Contact:
Last name:
yanli cheng, doctor
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
wei pei, doctor
Facility:
Name:
China-Japan Friendship Hospital
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Recruiting
Contact:
Last name:
shiyu du, doctor
Phone:
13911531937
Facility:
Name:
Aerospace Center Hospital
Address:
City:
Beijing
Zip:
100049
Country:
China
Status:
Recruiting
Contact:
Last name:
yuanmin zhu, doctor
Phone:
13811634389
Facility:
Name:
Beijing haidian hospital
Address:
City:
Beijing
Zip:
100080
Country:
China
Status:
Recruiting
Contact:
Last name:
yinyan guo, doctor
Facility:
Name:
Peking university third hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Zu, doctor
Phone:
15210325676
Email:
zuming7777@qq.com
Contact backup:
Last name:
shigang Ding, doctor
Phone:
15611908241
Email:
dingshigang222@163.com
Start date:
April 30, 2023
Completion date:
February 27, 2024
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870696
